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Amicus Therapeutics (FOLD)
NASDAQ:FOLD
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Amicus
(NASDAQ:FOLD)
63Neutral
Positive Factors
Expansion and Growth
The company announced new US PomOp manufacturing and in-licensed a Phase 3 drug for expansion.
Financial Performance
Amicus ended the first quarter with a strong financial position and does not anticipate any near-term impact from this.
Market Share and Sales
Galafold holds over 65% of the global amendable market share with an opportunity to move higher as mature markets are reaching 85-90% of market share.
Negative Factors
Guidance and Forecasts
Total revenue guidance for FY25 was lowered due to an unexpectedly higher UK VPAG rebate rate.
Patient Trends
The number of patients on treatment implies a plateauing of patient additions, which is not surprising given no new launch countries in recent quarters combined with the holiday season.
Revenue and Sales
Revenue for PomOp and Galafold missed expectations due to higher UK VPAG rebates.
Amicus (FOLD) vs. S&P 500 (SPY)
Market Cap
$2.36B
Dividend YieldN/A
Average Volume (3M)3.74M
Price to Earnings (P/E)―
Beta (1Y)0.74
Revenue Growth32.29%
EPS Growth64.39%
CountryUS
Employees499
SectorHealthcare
Sector Strength70
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.18
Shares Outstanding307,923,070
10 Day Avg. Volume3,849,680
30 Day Avg. Volume3,742,619
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)0.00
Price to Cash Flow (P/CF)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap1.27
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit6.33
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$15.86Price Target Upside106.51% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
Amicus Business Overview & Revenue Model
Company DescriptionAmicus Therapeutics, Inc., a biotechnology company, focuses on discovering, developing, and delivering medicines for rare diseases. Its commercial product and product candidates include Galafold, an oral precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data. It also develops AT-GAA, a novel treatment paradigm for Pompe disease; enzyme replacement therapies for Pompe diseases; CLN3, which is in Phase 1/2 clinical study to evaluate the safety and efficacy of a single intrathecal administration of an AAV serotype AT-GTX-502 gene therapy in patients with CLN3; and CDKL5, a gene on the X-chromosome encoding the CDKL5 protein that regulates the expression of essential proteins for normal brain development. The company has collaboration and license agreements with Nationwide Children's Hospital; University of Pennsylvania; and GlaxoSmithKline. Amicus Therapeutics, Inc. was incorporated in 2002 and is headquartered in Philadelphia, Pennsylvania.
How the Company Makes MoneyAmicus Therapeutics generates revenue through the sale of its approved therapies, primarily Galafold (migalastat), which is used to treat Fabry disease, a rare genetic disorder. The company earns money by commercializing its products in various global markets, leveraging strategic partnerships and collaborations to expand its reach. Additionally, Amicus invests in research and development to bring new therapies to market, which can lead to future revenue streams. Licensing agreements and collaborations with other pharmaceutical companies also contribute to its earnings, as they help to fund research and provide access to new technologies.
Amicus Financial Statement Overview
Summary
Amicus shows promising revenue growth with a 32.3% increase, but continues to face profitability challenges. The balance sheet reflects high leverage, posing risks, though there are signs of financial strengthening. Cash flow management is improving, yet negative free cash flow persists.Income Statement
Amicus has shown a positive trend in revenue growth, with a significant increase from $399.36 million in 2023 to $528.30 million in 2024, marking a 32.3% growth rate. Gross profit margin remains strong at approximately 90%, indicating efficient cost management. However, the net profit margin remains negative, reflecting ongoing challenges in achieving profitability. Positive EBIT margin improvement reflects enhanced operational efficiency, but negative EBITDA highlights ongoing financial pressures.65
Positive
Balance Sheet
The balance sheet shows a relatively high debt-to-equity ratio, indicating significant leverage, which poses a risk. However, the company has improved its equity position from previous years. Return on equity remains negative due to the net losses, but a gradually improving equity ratio suggests strengthening of the company's financial foundation.58
Neutral
Cash Flow
Operating cash flow has improved, narrowing the deficit from -$69.09 million to -$33.89 million, which indicates better cash management. However, free cash flow remains negative, and the free cash flow to net income ratio is unsatisfactory due to persistent net losses. Despite these challenges, the operating cash flow to net income ratio shows signs of improvement.50
Neutral
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 528.29M | 399.36M | 329.23M | 305.51M | 260.89M | Gross Profit |
| 475.35M | 362.03M | 290.63M | 271.05M | 229.84M | EBIT |
| 24.88M | -73.49M | -204.43M | -199.92M | -243.85M | EBITDA |
| 29.39M | -92.08M | -199.58M | -202.87M | -242.98M | Net Income Common Stockholders |
| -56.11M | -151.58M | -236.57M | -250.46M | -276.85M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 249.95M | 286.20M | 293.60M | 482.50M | 483.27M | Total Assets |
| 785.03M | 777.88M | 724.17M | 905.14M | 886.52M | Total Debt |
| 443.64M | 445.06M | 452.12M | 440.13M | 441.73M | Net Debt |
| 229.89M | 198.06M | 303.31M | 194.93M | 278.49M | Total Liabilities |
| 590.99M | 617.71M | 601.12M | 597.77M | 600.14M | Stockholders Equity |
| 194.04M | 160.17M | 123.05M | 307.37M | 286.38M |
| Cash Flow | Free Cash Flow | |||
| -37.44M | -76.53M | -170.34M | -206.38M | -236.52M | Operating Cash Flow |
| -33.89M | -69.09M | -166.57M | -202.49M | -233.29M | Investing Cash Flow |
| -560.00K | 98.06M | 92.32M | 78.76M | -13.58M | Financing Cash Flow |
| 5.12M | 61.68M | -7.46M | 212.07M | 262.86M |
Amicus Technical Analysis
Neutral
7.68
Price Trends
8.20
Negative
8.91
Negative
9.88
Negative
Market Momentum
-0.23
Negative
53.59
Neutral
96.26
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FOLD, the sentiment is Neutral. The current price of 7.68 is above the 20-day moving average (MA) of 7.11, below the 50-day MA of 8.20, and below the 200-day MA of 9.88, indicating a neutral trend. The MACD of -0.23 indicates Negative momentum. The RSI at 53.59 is Neutral, neither overbought nor oversold. The STOCH value of 96.26 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for FOLD.
Amicus Risk Analysis
Amicus disclosed 67 risk factors in its most recent earnings report. Amicus reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Amicus Peers Comparison
Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
63 Neutral | $2.36B | ― | -31.68% | ― | 32.29% | 64.39% | |
52 Neutral | $5.38B | 3.59 | -41.63% | 2.87% | 17.72% | 1.87% | |
50 Neutral | $3.12B | ― | -82.95% | ― | ― | -22.34% | |
50 Neutral | $2.41B | ― | -93.55% | ― | 97.02% | 64.32% | |
49 Neutral | $3.66B | ― | -214.50% | ― | 29.01% | 23.93% | |
48 Neutral | $3.13B | ― | -32.02% | ― | ― | -0.12% | |
45 Neutral | $2.62B | ― | -74.17% | ― | ― | -43.10% |
* Healthcare Sector Average
Performance Comparison
FOLD
Amicus
6.68
-3.75
-35.95%
RARE
Ultragenyx Pharmaceutical
38.97
-4.23
-9.79%
APLS
Apellis Pharmaceuticals
20.08
-27.41
-57.72%
SRRK
Scholar Rock Holding
32.91
17.81
117.95%
CRNX
Crinetics Pharmaceuticals
33.39
-13.39
-28.62%
IMVT
Immunovant
16.15
-12.63
-43.88%
Amicus Earnings Call Summary
Earnings Call Date:May 01, 2025
(Q1-2025)
| % Change Since: 0.00%|
Next Earnings Date:Jul 31, 2025
Earnings Call Sentiment Positive
The call presented a strong positive outlook with significant growth in key areas such as revenue and strategic collaborations, alongside challenges including higher than expected rebates and revised revenue guidance. However, the highlights, particularly the strong growth and strategic partnerships, outweigh the lowlights, indicating positive sentiment.Q1-2025 Updates
Positive Updates
Strong Double-Digit Revenue Growth
Amicus delivered its eleventh consecutive quarter of double-digit sales growth in its core business in Pompe and Fabry, with expectations for this trend to continue for years.
Strategic Collaboration with Dimerix
Amicus entered into a strategic collaboration with Dimerix, acquiring U.S. commercialization rights to DMX-200, a first-in-class compound in late Phase III development for a rare fatal kidney disease, with blockbuster market potential.
Onshoring Manufacturing to Strengthen Supply Chain
Amicus announced onshoring a portion of its drug product manufacturing to enhance its diversification strategy.
Galafold Revenue Growth and Market Share
Galafold revenue reached $104.2 million, up 6% at constant exchange rates, with a 14% increase in new patient starts and a 69% global market share of treated Fabry patients with amenable mutations.
Pombiliti and Opfolda Revenue Growth
Pombiliti and Opfolda revenue reached $21 million, up 92% at constant exchange rates, driven by significant growth in the U.S., Germany, and Spain.
Positive Outlook for DMX-200
The Phase III ACTION study for DMX-200 is progressing well, with FDA alignment on proteinuria as the primary endpoint for approval.
Negative Updates
Unexpected Rebate Impact in the UK
The UK's VPAG rebate was higher than anticipated, impacting revenue projections for both Galafold and Pombiliti and Opfolda.
Revised Revenue Guidance for Pombiliti and Opfolda
The full-year 2025 revenue growth guidance for Pombiliti and Opfolda was revised downwards from 65%-85% to 50%-65% at constant exchange rates.
Delayed Patient Starts in New Markets
Expected patient starts in newly reimbursed countries were delayed from Q1 to Q2, impacting immediate revenue projections.
Challenges with Nonlinear Order Patterns
Nonlinear order patterns outside the U.S. and unexpected factors impacted quarterly revenues for Galafold and Pom-Op.
Company Guidance
During the Amicus Therapeutics First Quarter 2025 Financial Results Conference Call, the company provided guidance that highlights several key metrics. The company reported a total revenue growth of 13% year-over-year, reaching $125.2 million, with a constant exchange rate growth of 15%. The revenue from Galafold reached $104.2 million, showing a 6% increase at constant exchange rates, while Pombiliti and Opfolda revenues increased by 92% to $21 million. Despite a higher-than-expected VPAG rebate in the UK impacting revenues, Amicus remains confident in achieving its full-year 2025 growth guidance for Galafold and revised its revenue growth guidance for Pombiliti and Opfolda to 50% to 65%. The company projects to reach combined sales of $1 billion by the end of 2028 for its two key products. Amicus also anticipates achieving GAAP profitability in the second half of 2025. The strategic collaboration with Dimerix and the expansion of their global supply chain further contribute to the company's positive outlook.Amicus Corporate Events
Product-Related AnnouncementsBusiness Operations and Strategy
Amicus Secures License for DMX-200 Development
Positive
May 1, 2025
On April 30, 2025, Amicus Therapeutics entered into a license agreement with Dimerix Bioscience, granting Amicus exclusive rights to develop, manufacture, and commercialize Dimerix’s drug candidate DMX-200 in the United States for Focal Segmental Glomerulosclerosis (FSGS) and other indications. This agreement, effective May 1, 2025, includes a $30 million upfront payment and potential milestone payments totaling up to $560 million. Dimerix will continue funding the ongoing pivotal Phase 3 study for DMX-200, while Amicus will handle regulatory submissions and commercialization in the U.S. This collaboration aims to bring a transformative treatment to patients with FSGS, a rare kidney disease with limited treatment options, enhancing Amicus’s portfolio in the rare disease market.
Spark’s Take on FOLD Stock
According to Spark, TipRanks’ AI Analyst, FOLD is a Neutral.
Amicus Therapeutics shows promising revenue growth and operational improvements but struggles with profitability and high leverage. Technical indicators suggest current downward momentum, though oversold conditions may indicate a potential rebound. Valuation metrics are weak due to negative earnings, but the positive outlook from the earnings call supports future growth prospects.
To see Spark’s full report on FOLD stock, click here.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.